Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma

Central Nervous System Neoplasms, Primary Clinical Trial

Official title:

Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03530605
• Other study ID #: Optune TTF in PCNSL
• Status: Withdrawn
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2020
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the overall survival (OS) time of elderly patients who would not tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those treated with whole-brain radiotherapy alone.

Standard treatment of primary central nervous system lymphoma (PCNSL) for patients with good performance status involves high-dose methotrexate-based chemotherapy regimens and whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years of age or older, little data exist with regard to optimal treatment of this patient population and they often do not qualify for clinical trials. In addition, elderly patients have a poorer rate of complete and partial response and increased risk of toxicity when treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy alone is often used in these patients to minimize toxic effects of more aggressive chemotherapies.

The Optune TTF device has proven effective in treating high-grade gliomas and is currently being investigated to treat meningiomas and metastatic lesions in the brain as well as other tumor types elsewhere in the body. It is generally well tolerated with no known systemic side effects, producing only an occasional local skin reaction. The mechanism of action is independent of tumor type and therefore may be effective in treating lymphoma as well.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Histological de novo diagnosis of PCNSL

• Tumor located in the supra-tentorial brain region

• Karnofsky performance score of 70 or above

• Ineligible for chemotherapy due to age or other co-morbidities

• Life expectancy of at least 3 months

• Patient has a caretaker willing to assist with study compliance

• Patient is able to provide written consent on their own behalf

Exclusion Criteria:

• Second or subsequent recurrence of PCNSL

• Patient wishes to receive systemic treatment

• Implanted electronic medical device in the brain (deep brain stimulator, vagus nerve stimulator, programmable shunt, etc.)

• Skull defect without replacement

• Prior radiation, surgery, or chemotherapy for PCNSL within the 4 weeks prior to enrollment

• Patient unable to comply with Optune device treatment or the study follow- up schedule

• Active participation in another therapeutic clinical trial

• Patient unable to provide written consent on their own behalf

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Neoplasms, Primary
• Lymphoma
• Nervous System Neoplasms

Intervention

Device:
• Optune TTF device
portable device which produces electrical fields

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	NovoCure Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival Time	Overall survival time	4 years
Secondary	Progression-Free Survival Time	Progression-free survival time	2 years
Secondary	One-Year Survival Rate	One-year survival rate	1 year
Secondary	Radiographic Response Rate	Tumor response by MRI measurement	2 years
Secondary	Steroid & Antiepileptic Use	use of concomitant steroids and antiepileptic use	2 years